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Study identifier: NCT07108530 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

Efficacy of Integrated Induction-Consolidation Chemotherapy and Transplantation for Adult Acute Myeloid Leukemia: Multicenter Study

Condition: Acute Myeloid Leukemia  ·  Sponsor: Shanxi Bethune Hospital

PhasePhase 2
Planned participants50
Who can joinAll sexes, 14 Years to 65 Years
Healthy volunteersNo

About this study

This is a multicenter, single-arm, open-label clinical study designed to evaluate the efficacy and safety of an integrated "induction-consolidation-transplantation" treatment protocol in adult patients with acute myeloid leukemia (AML, excluding M3 subtype). Based on patients' economic conditions, two induction regimens are offered: the IAV regimen (idarubicin + cytarabine + venetoclax) for those with better financial resources, and the DAV regimen (daunorubicin + cytarabine + venetoclax) for those with limited resources. During the consolidation phase, patients receive either the MA regimen (liposomal mitoxantrone + intermediate-dose cytarabine) or intermediate-dose cytarabine monotherapy. Eligible patients proceed directly to allogeneic hematopoietic stem cell transplantation (allo-HSCT), with a FA-BuCy/ATG conditioning regimen and an innovative graft-versus-host disease (GVHD) prophylaxis strategy using anti-CD25 monoclonal antibody combined with delayed oral cyclosporine. The entire treatment plan is designed to be completed within four months of diagnosis. The study plans to enroll 50 newly diagnosed patients aged 14-65 years. Primary endpoints include disease-free survival (DFS), complete remission rate (CR/CRi), and the efficacy of the transplantation protocol. Secondary endpoints include relapse rate, treatment-related mortality, 2-year overall survival, and treatment safety. This study aims to explore a new strategy to improve the cure rate of AML by optimizing drug …

This description comes directly from the study's public registry record.

Talk to the study team

Tao Wang, Dr.  ·  13835175119  ·  wangtao99699@163.com

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Locations (1)

Shanxi Bethune HospitalTaiyuan, Shanxi, ChinaRecruiting

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Source record: clinicaltrials.gov/study/NCT07108530